E-Z-GUARD MOUTHPIECE
Device Facts
| Record ID | K853402 |
|---|---|
| Device Name | E-Z-GUARD MOUTHPIECE |
| Applicant | E-Z-Em, Inc. |
| Product Code | BYP · Anesthesiology |
| Decision Date | Oct 23, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5620 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices.
